Encyclopedia Of Biopharmaceutical Statistics Second Edition

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Encyclopedia of Biopharmaceutical Statistics, Second Edition

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 9780824742614
Total Pages : 1000 pages
Book Rating : 4.7/5 (426 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics, Second Edition by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics, Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2003-06-04 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence. Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research. Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 135111025X
Total Pages : 4057 pages
Book Rating : 4.3/5 (511 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics - Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Encyclopedia of Biopharmaceutical Statistics

Author : Shein-Chung Chow
Publisher :
ISBN 13 : 9781351237123
Total Pages : pages
Book Rating : 4.2/5 (371 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages.US: (Tel) 1.888.318.2367; (E-mail) [email protected]: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]

Encyclopedia of Biopharmaceutical Statistics

Author : Shein-Chung Chow
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (837 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Encyclopedia of Biopharmaceutical Statistics, Third Edition

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 9781439822456
Total Pages : 0 pages
Book Rating : 4.8/5 (224 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics, Third Edition by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics, Third Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2010-05-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine

Encyclopedia of Biopharmaceutical Statistics

Author : Shein-Chung Chow
Publisher :
ISBN 13 :
Total Pages : 739 pages
Book Rating : 4.:/5 (837 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page 739 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Encyclopedia Of Biopharma- Ceutical Statistics

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 :
Total Pages : 562 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Encyclopedia Of Biopharma- Ceutical Statistics by : Shein-Chung Chow

Download or read book Encyclopedia Of Biopharma- Ceutical Statistics written by Shein-Chung Chow and published by CRC Press. This book was released on 2000 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process - highlighting the vital areas of statistical design and regulatory requirements." "Each entry of the Encyclopedia includes: self-contained, self-explanatory, and accessible data to nonbiostatisticians; "real-world" examples of statistical design and practice in the pharmaceutical industry; thoroughly up-to-date standards on good laboratory practice (GLP), good clinical practice (GCP), current good manufacturing practice (cGMP), and good statistics practice (GSP)." "Written by over 75 acclaimed international experts, the Encyclopedia of Biopharmaceutical Statistics explores interrelations among physiochemical properties of drugs in dosage form and their pharmacological, toxicological, and clinical effects; elucidates new applications of computer telephony technology; surveys the crucial relationship of the Food and Drug Administration (FDA) to pharmaceutical development, clinical trials and testing, and marketing; showcases monoclonal antibodies, cytokines, hematopoietic growth factors, tumor vaccines, xenotherapies, and cell-selection devices; describes one-sided equivalence and noninferiority trials; investigates genetic toxicology tests and other animal studies; illustrates assay technologies measuring gravimetric mass, potency, and physical or biological properties of analytes; discusses proposals for internationally standardized systems of data collection and analysis; and supplies vital economic data on factors such as reference-based pricing, burden-of-illness studies, cost-utility analysis, and cost-benefit analysis." "Containing over 2200 references, equations, tables, and drawings, the Encyclopedia of Biopharmaceutical Statistics serves as a reference for biostatisticians, chemists, pharmaceutical scientists, clinical researchers, and development pharmacists in the pharmaceutical industry and regulatory agencies, as well as upper-level undergraduate and graduate students in these disciplines."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved

Biopharmaceutical Statistics

Author : Shein-Chung Chow
Publisher :
ISBN 13 : 9780815363187
Total Pages : 0 pages
Book Rating : 4.3/5 (631 download)

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Book Synopsis Biopharmaceutical Statistics by : Shein-Chung Chow

Download or read book Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351110268
Total Pages : 2434 pages
Book Rating : 4.3/5 (511 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics - Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Basic Statistics and Pharmaceutical Statistical Applications, Second Edition

Author : James E. De Muth
Publisher : CRC Press
ISBN 13 : 9780849337994
Total Pages : 754 pages
Book Rating : 4.3/5 (379 download)

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Book Synopsis Basic Statistics and Pharmaceutical Statistical Applications, Second Edition by : James E. De Muth

Download or read book Basic Statistics and Pharmaceutical Statistical Applications, Second Edition written by James E. De Muth and published by CRC Press. This book was released on 2006-05-10 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Basic Statistics and Pharmaceutical Statistical Applications successfully provided a practical, easy-to-read, basic statistics book. This second edition not only updates the previous edition, but expands coverage in the area of biostatistics and how it relates to real-world professional practice. Taking you on a roller coaster ride through the world of statistics, Dr. De Muth clearly details the methodology necessary to summarize data and make informed decisions about observed outcomes. What's new or different in the Second Edition? New chapters cover: Measures of association primarily with nominal and ordinal data and and more than 15 tests Survival statistics including actuarial analysis and an introduction to multiple regression with survival data using proportional hazards regression An introduction to the topic of evidence-based practice with discussions of sensitivity and specificity, predictive values, and likelihood ratios Odds ratios and relative risk ratios that provide valuable information for dealing with probability, odds, and risk New sections address Power and sample size determination for two-sample Z-tests of proportions Clinical equivalence and noninferiority studies, process capability, and tolerance limits Methods for assessing repeatability and reproducibility Expanded information includes: Chi square, repeated measures designs, Latin Square designs, nine multiple comparison tests, and outlier testing Inverse prediction with linear regression, handling of multiple data points at different levels of independent variable, and assessment of parallelism of slopes for two samples Additional types of bivariate correlations and various assessments for independence and randomness More nonparametric tests including new information on post hoc comparisons for a significant Kruskal-Wallis test, the Kolmogorov-Smirnov goodness-of-fit test, and the Anderson-Darling test, as well as runs and range tests Eight new tables useful for the interpretation of some of the new inferential statistics De Muth provides concrete examples that enable you to effectively manage information in your day-to-day problem solving and reporting of findings. By avoiding heavy-duty mathematics and theory, even the mathematically challenged can benefit and increase their confidence in using statistics procedures.

Encyclopedia of Chemical Processing

Author : Sunggyu Lee
Publisher : Taylor & Francis US
ISBN 13 : 9780824755584
Total Pages : 720 pages
Book Rating : 4.7/5 (555 download)

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Book Synopsis Encyclopedia of Chemical Processing by : Sunggyu Lee

Download or read book Encyclopedia of Chemical Processing written by Sunggyu Lee and published by Taylor & Francis US. This book was released on 2006 with total page 720 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collecting information of vital interest to chemical, polymer, mechanical, electrical, and civil engineers, as well as chemists and chemical researchers, this "Encyclopedia "supplies nearly 350 articles on current design, engineering, science, and manufacturing practices-offering expertly written articles on technologies at the forefront of the field to maximize and enhance the research and production phases of current and emerging chemical manufacturing practices and techniques.

Encyclopedia of Chemical Processing (Online)

Author : Sunggyu Lee
Publisher : CRC Press
ISBN 13 : 1351237683
Total Pages : 3338 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Encyclopedia of Chemical Processing (Online) by : Sunggyu Lee

Download or read book Encyclopedia of Chemical Processing (Online) written by Sunggyu Lee and published by CRC Press. This book was released on 2005-11-01 with total page 3338 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition Encyclopedia supplies nearly 350 gold standard articles on the methods, practices, products, and standards influencing the chemical industries. It offers expertly written articles on technologies at the forefront of the field to maximize and enhance the research and production phases of current and emerging chemical manufacturing practices and techniques. This collecting of information is of vital interest to chemical, polymer, electrical, mechanical, and civil engineers, as well as chemists and chemical researchers. A complete reconceptualization of the classic reference series the Encyclopedia of Chemical Processing and Design, whose first volume published in 1976, this resource offers extensive A-Z treatment of the subject in five simultaneously published volumes, with comprehensive indexing of all five volumes in the back matter of each tome. It includes material on the design of key unit operations involved with chemical processes; the design, unit operation, and integration of reactors and separation systems; process system peripherals such as pumps, valves, and controllers; analytical techniques and equipment; and pilot plant design and scale-up criteria. This reference contains well-researched sections on automation, equipment, design and simulation, reliability and maintenance, separations technologies, and energy and environmental issues. Authoritative contributions cover chemical processing equipment, engineered systems, and laboratory apparatus currently utilized in the field. It also presents expert overviews on key engineering science topics in property predictions, measurements and analysis, novel materials and devices, and emerging chemical fields. ALSO AVAILABLE ONLINE This Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for both researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367; (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]

Encyclopedia of Soil Science

Author : Rattan Lal
Publisher : CRC Press
ISBN 13 : 9780849350542
Total Pages : 1052 pages
Book Rating : 4.3/5 (55 download)

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Book Synopsis Encyclopedia of Soil Science by : Rattan Lal

Download or read book Encyclopedia of Soil Science written by Rattan Lal and published by CRC Press. This book was released on 2006 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Upholding the high standard of quality set by the previous edition, this two-volume second edition offers a vast array of recent peer-reviewed articles. It showcases research and practices with added sections on ISTIC-World Soil Information, root growth and agricultural management, nitrate leaching management, podzols, paramos soils, water repellant soils, rare earth elements, and more. With hundreds of entries covering tillage, irrigation, erosion control, ground water, and soil degradation, the book offers quick access to all branches of soil science, from mineralology and physics, to soil management, restoration, and global warming."--Publisher's website.

Sample Size Calculations in Clinical Research, Second Edition

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1584889837
Total Pages : 480 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Sample Size Calculations in Clinical Research, Second Edition by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research, Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-08-22 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Advanced Medical Statistics (2nd Edition)

Author : Lu Ying
Publisher : World Scientific
ISBN 13 : 9814583324
Total Pages : 1472 pages
Book Rating : 4.8/5 (145 download)

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Book Synopsis Advanced Medical Statistics (2nd Edition) by : Lu Ying

Download or read book Advanced Medical Statistics (2nd Edition) written by Lu Ying and published by World Scientific. This book was released on 2015-06-29 with total page 1472 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book aims to provide both comprehensive reviews of the classical methods and an introduction to new developments in medical statistics. The topics range from meta analysis, clinical trial design, causal inference, personalized medicine to machine learning and next generation sequence analysis. Since the publication of the first edition, there have been tremendous advances in biostatistics and bioinformatics. The new edition tries to cover as many important emerging areas and reflect as much progress as possible. Many distinguished scholars, who greatly advanced their research areas in statistical methodology as well as practical applications, also have revised several chapters with relevant updates and written new ones from scratch.The new edition has been divided into four sections, including, Statistical Methods in Medicine and Epidemiology, Statistical Methods in Clinical Trials, Statistical Genetics, and General Methods. To reflect the rise of modern statistical genetics as one of the most fertile research areas since the publication of the first edition, the brand new section on Statistical Genetics includes entirely new chapters reflecting the state of the art in the field.Although tightly related, all the book chapters are self-contained and can be read independently. The book chapters intend to provide a convenient launch pad for readers interested in learning a specific topic, applying the related statistical methods in their scientific research and seeking the newest references for in-depth research.

Design and Analysis of Bioavailability and Bioequivalence Studies

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1420011677
Total Pages : 758 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Design and Analysis of Bioavailability and Bioequivalence Studies by : Shein-Chung Chow

Download or read book Design and Analysis of Bioavailability and Bioequivalence Studies written by Shein-Chung Chow and published by CRC Press. This book was released on 2008-10-15 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva

Multiple Comparisons and Multiple Tests Using SAS, Second Edition

Author : Peter H. Westfall
Publisher : SAS Institute
ISBN 13 : 1607648857
Total Pages : 645 pages
Book Rating : 4.6/5 (76 download)

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Book Synopsis Multiple Comparisons and Multiple Tests Using SAS, Second Edition by : Peter H. Westfall

Download or read book Multiple Comparisons and Multiple Tests Using SAS, Second Edition written by Peter H. Westfall and published by SAS Institute. This book was released on 2011 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: New and extensively updated for SAS 9 and later, this work provides cutting-edge methods, specialized macros, and proven best bet procedures. The book also discusses the pitfalls and advantages of various methods, thereby helping readers to decide which is the most appropriate for their purposes. 644 pp. Pub. 7/11.